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NCT01460615 Clinical Trial

Cortisone Treatment for the Prevention of Postoperative Pancreatitis and Pancreatitis-induced Complications After Pancreaticoduodenectomy and Distal Pancreatic Resection

Postoperative Complications Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01460615
Other study ID # R11009M
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date February 2011
Est. completion date January 2017

Study information
Verified date October 2011
Source Tampere University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this randomized, placebo-controlled trial is to investigate whether postoperative pancreatitis and other immediate complications after pancreaticoduodenectomy or distal pancreatic resection may be reduced with cortisone treatment. Treatment is administered to high risk patients (defined by high amount of acinar cells in the cut edge of pancreas).

Recruitment information / eligibility
Status Completed
Enrollment 0
Est. completion date January 2017
Est. primary completion date January 2017
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Pancreaticoduodenectomy and distal pancreatectomy patients in Tampere University Hospital

Exclusion Criteria:

- Patients with an ongoing cortisone treatment

- Cefuroxime allergy

- Chronic pancreatitis

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Hydrocortisone

Locations
Country Name City State
Finland Tampere University Hospital Tampere

Sponsors (1)
Lead Sponsor Collaborator
Tampere University Hospital

Country where clinical trial is conducted

Finland, 

Outcome
Type Measure Description Time frame Safety issue
Primary Postoperative overall complications of pancreatic resection e.g. Postoperative pancreatic fistula, delayed gastric emptying, postpancreatectomy hemorrhage, biliary fistula, wound infection, postoperative pancreatitis. within the first 30 days after surgery
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